CARVYKTI (Janssen-Cilag Pty Ltd)
Product name
CARVYKTI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
186 (255 working days)
Active ingredients
T cells - Ciltacabtagene autoleucel, cryopreserved - T - CARVYKTI
Registration type
Biologicals
Indication
Class 4 biological
CARVYKTI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.